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| Sponsored by: |
University of Padova |
|---|---|
| Information provided by: | University of Padova |
| ClinicalTrials.gov Identifier: | NCT00337740 |
Purpose
Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the two treatments was performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with high risk varices and no previous variceal bleeding are randomized to propranolol or variceal bleeding. Primary end point is variceal bleeding
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cirrhosis Esophageal Varices |
Procedure: endoscopic variceal banding Drug: propranolol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Study Comparing Ligation With Propranolol for Primary Prophylaxis of Variceal Bleeding in Candidates for Liver Transplantation |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lorenzo Norberto, prof | 0039-0498212211 | lorenzo.norberto@unipd.it |
| Italy | |
| Clinica Chirurgica 1^, Policlinico Universitario, Via Giustiniani 2 | Recruiting |
| Padova, Italy, 35128 | |
| Contact: Lorenzo Norberto, prof 0039-0498212211 lorenzo.norberto@unipd.it | |
| Principal Investigator: Lorenzo Norberto, prof., M.D. | |
| Principal Investigator: Umberto Cillo, prof. M.D. | |
| Sub-Investigator: Giacomo Zanus, M.D. | |
| Sub-Investigator: Lino Polese, M.D. | |
| Sub-Investigator: Patrizia Burra, MD | |
| Principal Investigator: | Lorenzo Norberto, prof, M.D. | University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic |
| Principal Investigator: | Umberto Cillo, prof. M.D. | University of Padova, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic |
| Study Director: | Francesco Grigoletto, prof, M.D. | Biostatistic and Epidemiology Unit, Department of Enviromental Medicine and Public Health, University of Padova, Italy |
| Study Chair: | Davide D'Amico, prof, MD | Padova University, Department of Surgical and Gastroenterological Sciences, 1st Surgical Clinic |
More Information
| Study ID Numbers: | TCPSVECE/9/01PD |
| Study First Received: | June 14, 2006 |
| Last Updated: | June 15, 2006 |
| ClinicalTrials.gov Identifier: | NCT00337740 |
| Health Authority: | Italy: Ministry of Health |
|
Liver Diseases Esophageal disorder Fibrosis Gastrointestinal Diseases Liver Cirrhosis Hypertension, Portal Hemorrhage Portal hypertension |
Esophageal varices Digestive System Diseases Propranolol Varicose Veins Esophageal and Gastric Varices Esophageal Diseases Hypertension |
|
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents |
